CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase II Study of CCI-779 in Combination With Rituximab in Patients With Relapsed or Refractory Mantle Cell Lymphoma
4 other identifiers
interventional
71
1 country
195
Brief Summary
This phase II trial is studying how well giving CCI-779 together with rituximab works in treating patients with relapsed or refractory mantle cell lymphoma. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving CCI-779 together with rituximab may kill more cancer cells
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2005
Longer than P75 for phase_2
195 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 3, 2005
CompletedFirst Posted
Study publicly available on registry
May 4, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
January 22, 2014
CompletedApril 17, 2014
December 1, 2013
4.3 years
May 3, 2005
December 3, 2013
March 21, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (Complete and Partial Responses) as Defined by the International Workshop Criteria
Complete Response (CR) - Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms. Partial Response (PR) requires a \>=50% decrease in sum of the products of the greatest dimension (SPD) of the six largest dominant nodes or nodal masses. Overall Response Rate (ORR) - The number of patients who achieve a CR or PR divided by the total number of evaluable patients. We report the Overall Response Rate here.
Up to 12, 28-day cycles.
Secondary Outcomes (4)
Time to Progression
Patients were followed up to five years after registration.
Duration of Response
Response duration is followed up to 5 years from registration.
Toxicity
Assessed during treatment (up to 12, 28-day cycles)
Overall Survival
Patients were followed for survival status for up to 5 years.
Study Arms (1)
Arm I
EXPERIMENTALPatients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
Interventions
375 mg/m\^2 Given IV
Eligibility Criteria
You may qualify if:
- Histologically confirmed\* mantle cell lymphoma (MCL)
- Relapsed, refractory, or stable disease after prior treatment
- Tumor must be cyclin D-1 by immunohistochemistry OR 11;14 translocation by fluorescent in situ hybridization or cytogenetics
- Measurable disease, defined as ≥ 1 of the following:
- Unidimensionally measurable lymph node or tumor mass ≥ 2 cm by CT scan or MRI
- Splenic enlargement if spleen is palpable ≥ 3 cm below the left costal margin
- Malignant lymphocytosis if absolute lymphocytic count ≥ 5,000 AND lymphocytes confirmed to be monoclonal by flow cytometry
- No known central nervous system involvement (e.g., parenchymal mass or leptomeningeal involvement)
- Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2
- At least 3 months
- No other concurrent treatment for MCL
- Absolute neutrophil count ≥ 1,000/mm\^3
- Platelet count ≥ 75,000/mm\^3
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Direct bilirubin \< 1.5 times ULN
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (195)
Mobile Infirmary Medical Center
Mobile, Alabama, 36607, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Boulder Community Hospital
Boulder, Colorado, 80301, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Saint Anthony Central Hospital
Denver, Colorado, 80204, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Exempla Saint Joseph Hospital
Denver, Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Colorado Cancer Research Program CCOP
Denver, Colorado, 80224-2522, United States
Swedish Medical Center
Englewood, Colorado, 80110, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81502, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Longmont United Hospital
Longmont, Colorado, 80501, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Rush - Copley Medical Center
Aurora, Illinois, 60504, United States
Saint Joseph Medical Center
Bloomington, Illinois, 61701, United States
Graham Hospital Association
Canton, Illinois, 61520, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
Eureka Hospital
Eureka, Illinois, 61530, United States
Galesburg Clinic
Galesburg, Illinois, 61401, United States
Galesburg Cottage Hospital
Galesburg, Illinois, 61401, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hopedale Medical Complex - Hospital
Hopedale, Illinois, 61747, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, 60435, United States
Kewanee Hospital
Kewanee, Illinois, 61443, United States
Mcdonough District Hospital
Macomb, Illinois, 61455, United States
Bromenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center Foundation
Normal, Illinois, 61761, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, 61350, United States
Pekin Cancer Treatment Center
Pekin, Illinois, 61554, United States
Pekin Hospital
Pekin, Illinois, 61554, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61603, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Illinois Oncology Research Association CCOP
Peoria, Illinois, 61615, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois Valley Hospital
Peru, Illinois, 61354, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
Saint Margaret's Hospital
Spring Valley, Illinois, 61362, United States
Carle Clinic-Urbana Main
Urbana, Illinois, 61801, United States
Carle Foundation dba Carle Cancer Center
Urbana, Illinois, 61801, United States
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, 46107, United States
Saint Anthony Memorial Health Center
Michigan City, Indiana, 46360, United States
Reid Hospital and Health Care Services
Richmond, Indiana, 47374, United States
McFarland Clinic
Ames, Iowa, 50010, United States
Saint Luke's Hospital
Cedar Rapids, Iowa, 52402, United States
Cedar Rapids Oncology Association
Cedar Rapids, Iowa, 52403, United States
Mercy Hospital
Cedar Rapids, Iowa, 52403, United States
Oncology Associates
Cedar Rapids, Iowa, 52403, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325, United States
Mercy Capitol
Des Moines, Iowa, 50307, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Iowa Oncology Research Association CCOP
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates
Des Moines, Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Mercy Medical Center - North Iowa
Mason City, Iowa, 50401, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101-1733, United States
Siouxland Hematology - Oncology Associates
Sioux City, Iowa, 51101, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, 51104, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Hospital District Sixth of Harper County
Anthony, Kansas, 67003, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
Associates In Womens Health
Wichita, Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas - Main Office
Wichita, Kansas, 67214, United States
Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Wichita CCOP
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
Bixby Medical Center
Adrian, Michigan, 49221, United States
Hickman Cancer Center
Adrian, Michigan, 49221, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, 48106, United States
Oakwood Hospital
Dearborn, Michigan, 48123, United States
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Hurley Medical Center
Flint, Michigan, 48502, United States
Genesys Regional Medical Center
Flint, Michigan, 48532, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Community Cancer Center of Monroe
Monroe, Michigan, 48162, United States
Mercy Memorial Hospital
Monroe, Michigan, 48162, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341-2985, United States
Saint Joseph Mercy Port Huron
Port Huron, Michigan, 48060, United States
Saint Mary's of Michigan
Saginaw, Michigan, 48601, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Merit Care Clinic Bemidji
Bemidji, Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Duluth Clinic CCOP
Duluth, Minnesota, 55805, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Saint Mary's Medical Center
Duluth, Minnesota, 55805, United States
Fairview-Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, 59101, United States
Montana Cancer Consortium CCOP
Billings, Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Billings Clinic
Billings, Montana, 59107-7000, United States
Deaconess Medical Center
Billings, Montana, 59107, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Northern Montana Hospital
Havre, Montana, 59501, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Glacier Oncology PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Community Medical Hospital
Missoula, Montana, 59801, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, 59804, United States
Rutherford Hospital
Rutherfordton, North Carolina, 28139, United States
Bismarck Cancer Center
Bismarck, North Dakota, 58501, United States
Medcenter One Health Systems
Bismarck, North Dakota, 58501, United States
Mid Dakota Clinic
Bismarck, North Dakota, 58501, United States
Saint Alexius Medical Center
Bismarck, North Dakota, 58501, United States
Meritcare Hospital
Fargo, North Dakota, 58122, United States
MeritCare Medical Group
Fargo, North Dakota, 58122, United States
Wood County Oncology Center
Bowling Green, Ohio, 43402, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Health Center
Dayton, Ohio, 45415, United States
Veteran Affairs Medical Center
Dayton, Ohio, 45428, United States
Dayton CCOP
Dayton, Ohio, 45429, United States
Hematology Oncology Center Incorporated
Elyria, Ohio, 44035, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Fremont Memorial Hospital
Fremont, Ohio, 43420, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Cole, Sharon, K. M.D. (UIA Investigator)
Kenton, Ohio, 43326, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
Northwest Ohio Oncology Center
Maumee, Ohio, 43537-1839, United States
Saint Luke's Hospital
Maumee, Ohio, 43537, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, 43537, United States
Bayview Oncology Associates
Oregon, Ohio, 43616, United States
Saint Charles Hospital
Oregon, Ohio, 43616, United States
Firelands Regional Medical Center
Sandusky, Ohio, 44870, United States
North Coast Cancer Care
Sandusky, Ohio, 44870, United States
Flower Memorial Hospital
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
The Toledo Hospital
Toledo, Ohio, 43606, United States
Saint Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
University of Toledo
Toledo, Ohio, 43614, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, 43617, United States
Mercy Cancer Center at Saint Anne Mercy Hospital
Toledo, Ohio, 43623, United States
Stark, Michael, Edward. M.D. (UIA Investigator)
Toledo, Ohio, 43623, United States
Toledo Clinic
Toledo, Ohio, 43623, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
Clinton Memorial Hospital
Wilmington, Ohio, 45177, United States
Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, 18711, United States
AnMed Health Hospital
Anderson, South Carolina, 29621, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Upstate Carolina CCOP
Spartanburg, South Carolina, 29303, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, 57105, United States
Fredericksburg Oncology Inc
Fredericksburg, Virginia, 22401, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
Related Publications (1)
Ansell SM, Tang H, Kurtin PJ, Koenig PA, Inwards DJ, Shah K, Ziesmer SC, Feldman AL, Rao R, Gupta M, Erlichman C, Witzig TE. Temsirolimus and rituximab in patients with relapsed or refractory mantle cell lymphoma: a phase 2 study. Lancet Oncol. 2011 Apr;12(4):361-8. doi: 10.1016/S1470-2045(11)70062-6.
PMID: 21440503DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stephen M. Ansell, M.D., Ph.D.
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Ansell
North Central Cancer Treatment Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2005
First Posted
May 4, 2005
Study Start
May 1, 2005
Primary Completion
September 1, 2009
Study Completion
March 1, 2012
Last Updated
April 17, 2014
Results First Posted
January 22, 2014
Record last verified: 2013-12